Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Local ablation is a safe and effective therapy for patients who cannot undergo resection, or
as a bridge to transplantation. Of the various percutaneous local ablative therapies,
radiofrequency ablation (RFA) has attracted the greatest interest because of its
effectiveness and safety for small HCC ≤ 5.0 cm, with a 3-year survival rate of 62% to 68%,
a low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%.
Prospective randomized trials have shown RFA to be better than percutaneous ethanol
injection (PEI) in producing a higher rate of complete tumor necrosis with fewer numbers of
treatment sessions and better survival.
Unfortunately, the complete tumor necrosis rate for tumors larger than 5 cm is less
favorable, and the local recurrence rate can be as high as 20% even in small HCC less than
3.5 cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA
or adjacent microscopic satellite tumor nodules.
Transcatheter Arterial Chemoembolization (TACE) has proven to be an effective and palliative
therapy for unresectable HCC. And some prospective randomized controlled trials have shown
that adjuvant TACE after curative resection for HCC can improve the overall survivals and
decrease the recurrence rates. But there have not been any studies about TACE as an adjuvant
therapy after RFA for HCC.
Thus, the purpose of this study is to prospectively evaluate whether TACE as an adjuvant
therapy after RFA for HCC will improve the outcomes of RFA.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
3, and 5-years
Min-Shan Chen, M.D., Ph.D.
Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University
China: Ministry of Health